The primary objective is to measure R2 latencies, amplitude, duration, area and habituation of the electrically evoked *nociception specific* blink reflex before and after treatment with oxygen at a flow rate of 12 L/min during a cluster headache…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints are differences in R2 latency, amplitude, duration,
area and habituation measured on both sides between the time points: before a
cluster headache attack (without oxygen treatment), immediately after start of
the cluster headache attack and after 12-15 minutes of oxygen treatment for the
cluster headache attack.
Secondary outcome
The secondary study endpoints are differences in change of R2 latencies,
amplitudes, durations, areas and habituation in the 12-15 minutes of oxygen
treatment between the groups: clear responders (reduction of pain of at least
50% within 15 minutes after the start of oxygen inhalation) and non-responders
plus moderate responders (reduction of pain of less than 50% within 15 minutes
after the start of oxygen inhalation); differences in R2 latency, amplitude,
duration, area and habituation at the aforementioned 3 time points between the
symptomatic and asymptomatic side; differences in R2 latency, amplitude,
duration, area and habituation before a cluster headache attack without and
with oxygen treatment.
Background summary
In order to further unravel the pathophysiology of cluster headache, we want to
determine the location at which oxygen exerts its pain reducing effects in
humans. We hypothesize a neurogenic effect of oxygen at brainstem level. As a
substitute for measurement of impairment of parasympathetic outflow and to
determine the influence of interneurons on the trigemino-facial reflex arch, we
will look at the effect of oxygen on medullary interneurons by using the
*nociception specific* blink reflex.
Study objective
The primary objective is to measure R2 latencies, amplitude, duration, area and
habituation of the electrically evoked *nociception specific* blink reflex
before and after treatment with oxygen at a flow rate of 12 L/min during a
cluster headache attack.
Study design
Repeated measures: the *nociception specific* blink reflex will be measured
before a spontaneous cluster headache attack (without and with oxygen
treatment), shortly after the onset of the attack and 12-15 minutes after the
start of treatment with 100% oxygen.
Intervention
All patients will be treated with 100% percent oxygen at a flow rate of 12
L/minute, given 3 minutes after pain onset for 15 minutes, using a
non-rebreathing facial mask.
Study burden and risks
Before starting the first blink reflex measurement patients will have to fill
in a questionnaire. * Patients will undergo at least four blink reflex
measurements during one visit: the blink reflex will be elicited every 2 hours
before the onset of a cluster headache attack without oxygen treatment, once
before the onset of a cluster headache attack during oxygen treatment, at the
onset of the cluster headache attack and 12-15 minutes after the start of
oxygen treatment. The stimulations during the blink reflex measurements will
produce a pinprick-like pain. * During the first 3 minutes of the cluster
headache attack (i.e. during the first blink reflex measurement during the
cluster headache attack) the patient will not receive oxygen treatment.
However, we assume that this reflects the patient*s situation at home. * Oxygen
entails a fire hazard. Very rare side effects of oxygen treatment are pleuritis
and respiratory distress syndrome. * The VAS pain score (of 0-10) will be asked
for at the onset of the cluster headache attack, at 3 minutes after the onset
of the cluster headache attack (i.e. at the start of oxygen treatment) and at
15 and 18 minutes after the onset of the cluster headache attack.
The study will not provide an immediate benefit for the individual
participating patient. This study will contribute to a better understanding of
cluster headache pathophysiology. A better understanding of the disease
pathophysiology will lead to more targeted and therefore probably more
effective treatment or applications of treatment in the future, leading to
better pain relief and/or prevention of pain.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
Inclusion criteria
1. Episodic or chronic cluster headache according to the ICHD-II criteria , diagnosed by a neurologist.
2. Episodic cluster headache patients have to be in a cluster period.
3. Age 18-70 years.
Exclusion criteria
1. Secondary cluster headache, as diagnosed by the patient*s neurologist.
2. Other primary or secondary headache diagnoses or other painful conditions which could interfere with the patient*s pain perception.
3. Pregnancy or lactation.
4. Chronic obstructive pulmonary disease and other contraindications for oxygen therapy.
5. Intolerability of the oxygen face mask.
6. Rebound cluster headache following oxygen therapy .
7. Previous surgical treatment of the trigeminal nerve or thermolesion of the sphenopalatine ganglion.
8. Side change of cluster headache in the previous year.
9. Incapacitation to understand and sign for informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41155.096.12 |